The Icellator2 system set the standard, providing SVF cell yields in 65 minutes. Currently approved for use in The Bahamas and available in Japan. In the USA, clinical FDA-approved IDE studies using the Icellator® are underway for a variety of indications.
THE ICELLATOR2 BENEFITS
- Consistently isolates high stromal vascular fraction (SVF) cell yields.
- Includes multiple types of adult stem cells.
- Provides cell product in about an hour.
- Interface available in multiple languages.
INSTRUMENT OPERATION
- The Icellator2 is designed for maximum simplicity in use by clinical staff.
INTERFACE
- Interactive touch-screen user interface simplifies operation.
- Totally enclosed and automated process.
- Interface available in multiple languages.
- Intelligent process algorithms enhance performance and reliability.
SYSTEM SPECIFICATIONS
- Input Voltage: 100-120 or 220-240 V (depending upon factory configuration)
- Current: 6.3A MAX
- Frequency: 50-60 Hz
DIMENSIONS
- Width: 27” (69 cm)
- Height: 13” (33 cm)
- Depth: 22.5” (57 cm)
- Weight: 123 lbs./56 kg
The Icellator2 chassis fits within the footprint of a 30” cart
HIGHLIGHTS
- The new Icellator2 is a state-of-the-art, enzyme-derived stem cell isolation system.
- Effective with minimal amount of adipose tissue.
- Totally enclosed and automated process.
- Temperature control optimizes SVF yield per mL of adipose tissue.
- Cell suspension safe for IV delivery.
- Features a sterile, single-use, disposable kit.
- Minimizes risk for human error and contamination.
- Manufactured in accordance with FDA cGMP and ISO 13485 standards.
- IEC 61010 & 60601 compliant
- Ready for operating rooms, clinics and research labs. In USA, FDA IDE required.
- Input Lipoaspirate Volume: 60 – 100 mL
- Typical cell recovery for 100 mL: 50 million1
- Run Time: approx. 1 hour
1. Doi, K., Tanaka, S., Iida, H., Eto, H., Kato, H., Aoi, N., Kuno, S., Hirohi, T. and Yoshimura, K. (2013), Stromal vascular fraction isolated from lipo-aspirates using an automated processing system: bench and bed analysis. J Tissue Eng Regen Med, 7: 864–870. doi:10.1002/term.1478
CELL ICELLATIONTM KIT FOR THE ICELLATOR2
THE ICELLATOR2 ICELLATION KIT BENEFITS
UNIQUE INTEGRATED DIGESTION, WASHING AND RESUSPENSION
- Injection port for addition of adipose tissue.
- Delivers final cell product to integrated syringe for immediate use.
- Sterile end-to-end cell isolation path.
- Proprietary Adipase® enzyme enables the highest possible yield of viable cells per ml of lipoaspirate.
- Automated addition of Adipase enzyme for temperature-controlled tissue and separation process leads to efficient SVF isolation1.
1. Joel A. Aronowitz, Ryan A. Lockhart, Cloe S. Hakakian (2015), Mechanical versus enzymatic isolation of stromal vascular fraction cells from adipose tissue: 4:713 DOI 10.1186/s40064-015-1509-2
HIGHLIGHTS
- Sterile, single-use disposable kit using adipose tissue for high efficiency enzyme derived SVF isolation with Icellator2.
- Functionally closed system.
- Minimizes process and cell product variability.
- Temperature controlled digestion and separation.
- Class III approval for commercial use by the South Korean Ministry of Food and Drug Safety (MFDS).
- Approved for clinical use in South Korea & The Bahamas.
- In the USA, FDA-approved clinical IDE studies using the Icellator and Cell Icellation Kit are underway for multiple indications.
- Produced under ISO 13485 according to 21 CFR 820 (GMP).
DELIVERS CELL PRODUCT READY FOR USE
- Delivers cell product into a syringe ready for immediate use.
- Minimizes sterile breaks and opportunity for contamination.
- Once loaded with a replacement Icellation kit, the Icellator2 is immediately ready for the next patient’s sample.
DESIGN AND AUTOMATION
- Gamma-irradiated, sterile polycarbonate cell separation and centrifugation chamber with double wall construction and optimized separation geometry.
- Transparent construction for real-time observation.
- Precision stainless cannulas for filling and aspiration.
- Luer injection port and cap for lipoaspirate loading.
- Motion Industries® precision high-rpm load bearing and nitrile pneumatic seal with resistive torque arm.
- Sterile fluid control polyallomer matrix assembly for controlling liquid flow during automated processing.
- Platinum silicon tubing assembly, Versapor® vents and custom solids filtration.
- Sterile ethylene vinyl acetate solution reservoir for wash buffer.
- 30 mL amber glass vial, aseptically-filled with lyophilized Adipase custom formulated for the digestion of adipose tissue.
SINGLE-USE STERILE PLASTIC KIT
- Produced under ISO 13485 and according to 21 CFR 820 (GMP).
- Manufactured in an ISO 7 Cleanroom.
- Sterilized by gamma irradiation.
- Nonpyrogenic.
© Copyright 2021 Orgenesis Inc. All rights reserved. “Tissue Genesis”, “Tissue Genesis Icellator Cell Isolation System”, ”Icellator”, ”Icellator X”, Icellator2 and “Adipase” are all registered trademarks of Orgenesis Inc. “Icellation” is a pending trademark of Orgenesis, Inc. Product images and descriptions contained herein are for informational purposes only. The information contained herein is subject to change without notice. Orgenesis, Inc shall not be liable for errors contained herein for consequential damages in connection with the furnishing, performance, or use hereof.
CAUTION: Investigational device. Limited by law in the United States to investigational use.
